PALINA: A phase II safety study of palbociclib in combination with letrozole or fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer

Contemporary Clinical Trials Communications
Filipa LynceClaudine Isaacs

Abstract

Palbociclib has been shown to be a highly effective therapy in hormone receptor positive metastatic breast cancer when used in combination with letrozole or fulvestrant. Grade 3/4 neutropenia is a common side effect although febrile neutropenia is relatively uncommon. Insufficient data exist to describe the hematological safety of palbociclib in African American women (AAW) known to have a high incidence of benign ethnic neutropenia (BEN). PALOMA 1, 2 and 3, the initial phase II/III studies that led to the U.S. Food and Drug Administration (FDA) approval of palbociclib in metastatic breast cancer, only included participants with baseline absolute neutrophil count (ANC) of 1500/mm3 or higher. African American women (AAW) were underrepresented in the PALOMA trials and this may be partially explained by strict requirements for minimal ANC ≥1500/mm3. The ANC of 1500/mm3 for initiation of treatment in those with BEN has been previously challenged. In this study, we propose to lower the ANC cutoff for enrollment to 1000/mm3. PALINA (NCT02692755) is a phase II, single arm, multicenter clinical trial that will enroll 35 patients. The primary endpoint is to assess the proportion of patients who complete therapy without the development o...Continue Reading

Citations

Oct 2, 2020·CA: a Cancer Journal for Clinicians·Mina S SedrakUNKNOWN Cancer and Aging Research Group (CARG)
Jun 24, 2021·American Society of Clinical Oncology Educational Book·Erica M Stringer-ReasorLisa A Newman
Jun 29, 2021·Expert Review of Anticancer Therapy·Komal JhaveriGeoffrey I Shapiro
Aug 8, 2021·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·E PanagiotouE Kotteas

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Clinical Trials Mentioned

NCT02692755

Software Mentioned

PALINA

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